The objective was to ascertain if Ginkgo biloba benefits patients with tinnitus. The study design was: 1. Randomized double blind trial of Ginkgo biloba versus placebo; 2. A meta-analysis of randomized placebo controlled double blind trials. Participants included 66 adult patients with tinnitus and six (including our study) randomized placebo controlled double blind trials were meta-analysed. The main outcome measures were the Tinnitus Handicap Inventory (THI), Glasgow Health Status Inventory (GHSI) and average of hearing threshold at 0.5, 1, 2, 4 kHz. In the meta-analysis the proportion of patients gaining benefit and an overall odds ratio were determined. The results showed the mean difference in change of the THI, GHSI and hearing between Ginkgo biloba (n = 31) and placebo group (n = 29) was 2.51 (CI -10.1, 5.1, P = 0.51), 0.58 (CI-4.8, 3.6, P = 0.38) and 0.68 db (CI -4.13, 2.8, P = 0.69). Meta-analysis revealed 21.6% of Ginkgo biloba treated patients (n = 107/552) gained benefit versus 18.4% (n = 87/504) of placebo treated patients with an odds ratio of 1.24 (CI 0.89, 1.71). In conclusion, Ginkgo biloba does not benefit patients with tinnitus.

Background A 2017 systematic review suggested patient engagement in clinical trials has been limited, with little active engagement in trial design or data analysis, interpretation or dissemination. Additionally, there remains limited sex/gender reporting in clinical trial research. Objectives The overall goal of this project was to disseminate sex/gender knowledge and build capacity for patient engagement in clinical trials. Specific objectives were to (1) create capacity and identify opportunities for patient engagement in clinical trials and sponsor-or investigator-led activities (e.g. clinical trial design and conduct); and (2) enhance new/early investigator sex/gender knowledge and skills related to patient-oriented research (POR). Methods We used the Canadian Institutes of Health Research Strategy for Patient-Oriented Research (SPOR) Capacity Development Framework and the SPOR Patient Engagement Framework to guide three phases of this project: (1) conduct a scoping review using methods described by the Evidence for Policy and Practice Information (EPPI) and the Coordinating Centre at the Institute of Education (Phase 1); (2) host a 1-day POR consultation workshop (Phase 2); and (3) deliver a new/early investigator POR training day (Phase 3). Six electronic databases (CINAHL, MEDLINE, EMBASE, PsychInfo, the Cochrane Library, and AMED) were searched from 1996 using keywords and Medical Subject Heading (MeSH) terms in accordance with the International Association for Public Participation (IAP2) and the search criteria in the bibliographic databases. Standard approaches were used to search the grey literature. Results A total of 79 studies and over 150 websites were subject to data abstraction by team members, capturing information on sex/gender and SPOR's patient engagement guiding principles of inclusiveness, support, mutual respect, and co-building. Results were presented to 32 key stakeholders at the consultation workshop and input was sought on next steps using nominal group techniques. Based on the plethora of existing POR resources, relevant POR information from the scoping review was collated into two decision aids (patient and investigator) to determine readiness to engage with/as a patient partner in a clinical trial. The decision aids were presented at a POR training day with 88 new/early investigators, clinicians, patient partners and decision makers. The decision aids showed 'good' usability, assessed using the System Usability Scale (SUS). Attendees thought the decision aids were engaging, they increased their understanding of sex/gender, patient engagement and POR, and they would recommend them to others. POR principles and practices were integrated across all phases of the project. Patient partners (1) identified research priorities/search terms; (2) collected/analyzed data; (3) designed the patient partner decision aid; and (4) disseminated the results through presentation. Conclusion Our digital patient partner and investigator decision aids are the first to provide information technology to d...

Background The reporting quality of physical activity (PA) programs in randomized controlled trials (RCTs) for the management of juvenile idiopathic arthritis (JIA) remains unknown. This study aimed to assess and compare the reporting quality of PA programs in RCTs for the management of JIA using three difference standardized assessment tools, and to describe the elements that were similar and different between these tools. Methods A systematic search was conducted for moderate-to high-quality RCTs of PA programs in JIA, published up until January 2019. Two reviewers independently included 10 RCTs and scored the reporting quality of PA programs using the following tools: Consensus on Exercise Reporting Template (CERT) checklist, Consensus on Therapeutic Exercise Training (CONTENT) scale, and Template for Intervention Description and Replication (TIDieR) checklist. Results Results showed that reporting of PA programs in 10 moderate- to high-quality RCTs for JIA management remains incomplete. The average reporting quality (± standard deviation) for all RCTs combined was moderate for the three standardized assessment tools with 70.8 (±14.3)% for the TIDieR checklist, 53.2 (±20.2)% for the CERT checklist, and 70.0 (±18.9)% for the CONTENT scale. Despite some overlap, the three standardized assessment tools (TIDieR, CERT, CONTENT) included different elements resulting in different scores. All tools assess elements linked to PA programs (provider, location, timing, personalization and adherence), but the CERT checklist includes other essential elements (e.g., additional resources, motivational strategies, adverse events). Conclusions The lack of complete reporting of PA programs in RCTs for the management of JIA and the variation in scores and assessed elements among standardized assessment tools show the need to improve reporting. Using the most comprehensive standardized tool (i.e., the CERT) and providing accessible supplemental information on PA programs may improve the reporting quality of PA programs in RCTs and help reproduce PA programs in research and clinical practice.

Child and adolescent mental health (CAMH) problems are prevalent and inefficient mental health (MH) care systems can contribute to poor outcomes. The Choice and Partnership Approach (CAPA) is a MH care delivery model aiming to provide efficient, high-quality care. Although widely used, no CAPA research review exists. We conducted a scoping review to fill this gap. Medline, Embase, and PsycINFO databases were searched from inception to June 2021. Grey Matters and Google were used to search the grey literature. We identified 5322 records. Removal of duplicates left 4720 documents, which were successively screened and data extracted by pairs of co-authors. The final dataset comprised six published and three non-published studies, conducted primarily at CAMH sites in England, Scotland, Australia, or Canada. Each study had multiple research objectives, which we summarized into seven categories. Positive outcomes were reported for most objectives, but attributing causality to CAPA was hampered by research methodology. Observational designs were used in all studies and approaches to analyzing data varied considerably. Research gaps included the lack of healthcare economics studies of CAPA and no assessment of facilitators and barriers. Current research on CAPA provides intriguing findings meriting further investigation. We suggest strategies to improve future studies.

A BMJ collection urges decision makers to reverse decades of neglect